This invention relates to external catheters in use with male patients, and more particularly to the improvement wherein one or a plurality of flap member components are provided therewith for assisting in the application of the catheter upon the penis.
It is commonplace in a variety of clinical situations for patients to lose control of the discharge of urine. It is generally preferable to avoid transurethral catheterization of the urinary bladder, as infection, discomfort, or internal injury can result. Accordingly, an external, condom-like catheter is often employed as an alternative to an invasive catheterization of the male patient.
The typical external catheter, also called a "condom" or "Texas" catheter, generally comprises an elongated, circularly tubular device of one-piece construction having a stem section defining a fluid passage, an intermediately-positioned conical or cup-shaped mid-portion providing a forward discharge opening in communication with the fluid passage, and a relatively flexible, thin-walled sleeve member dimensioned to extend over and cover the penis. In catheters of this type, the sleeve member is prepared in an initial rolled-up attitude to reside in the vicinity of the conical mid-portion, and is manually unrolled over the penis during the application procedure. Also in catheters of this type, the sheath member may have an adhesive substance on it inner wall surface to adhesively engage the penis and to effect a liquid-tight seal. Alternatively, the catheter may be constructed without such an inner-surface adhesive on its sleeve member, whereupon an encircling band of adhesive-surfaced foam tape, placed about the unrolled portion of the device, is intended to effect a liquid-tight seal between catheter and penis and to help hold the device in place, according to one method of practice. Additionally in catheters of this type, the stem section of the device may present a dilation at the base of the mid-portion which serves as a surge chamber and acts as an anti-kink mechanism.
To function as intended, it is desirable to place and maintain the free end of the penis in near approximation to the forward discharge opening of the external catheter. When the free end of the penis is maintained within the catheter in such a position during external catheterization, a twisting, collapsing, or kinking of the catheter to a degree which restricts the outflow of urine or contributes to an ill-fitting of the device is largely prevented.
Unfortunately, improper positioning and poor fit are common problems associated with the typical external or condom-like catheter. Often encountered when applying the device to the penis are problems which occur when the catheter sleeve member is unrolled over the penis. It has been observed that the act of unrolling the sleeve member of the catheter tends to push the free end of the penis away from the forward discharge opening and out of an intended position within the conical mid-portion of the catheter, contributing to an improper fit of the device upon the penis. It has also been observed that the relative looseness of the penile skin tends to cause the same to be pushed ahead of the catheter roll as the sleeve member of the catheter is unrolled, displacing the penile skin rearwardly away from a normal, relaxed position. In this eventually, after the catheter is unrolled, the penile skin will then return to a relaxed state and cause the free end of the penis to displace and withdraw from the intended position within the mid-portion of the catheter, leading to the aforementioned problems associated with an improper positioning and fit of the device.
In the related, above-identified U.S. patent application, herein incorporated by reference, a substantial improvement in the external, condom-like catheter is disclosed and entails the provision of one or more flap members which are intergral with the device and which project from an interior location on or near the conical mid-portion of the catheter. The flap member or members provide an adhesive surface which can adhesively engage the penis prior to an unrolling of a rearward portion (or, as it is called in this disclosure, a sleeve member) of the catheter over the penis, in address of the above-mentioned problems associated with the typical external or condom-like catheter. Removable cover slips may be provided to protect the adhesive surface of the flap member (s) prior to an intended procedure for applying the catheter to the penis. According to the prior disclosure, the flap member or members may be a formed and component extention of the elastomer material common to the remainder of the catheter device. Alternatively, the flap member or members of the parent disclosure may be constructed separately and then suitably bonded to the catheter at an appropriate location.
With the foregoing in mind, it has been found suitable to use, as flap members, short strips of medically-approved, adhesive-surfaced flexible foamed tapes, bonded on their non-adhesive side to suitable catheter locations. In a further advance of the art, it has been discovered that the foamed tapes can be attached to what may be considered an external location on the catheter, rather than attached to what may ordinarily be regarded as in inner location on the catheter and a more difficult attachment to achieve.
It is, therefore, one object of the present invention to provide a condom catheter with members which will act to prevent an unrolling sleeve member from pushing the free end of the penis away from a forward discharge opening and which will prevent the same from pushing the penile skin ahead of the roll during the application procedure.
It is a further object of the present invention to provide a method of manufacturing an external catheter having one or a plurality of secondarily-attached flap members connected to said catheter in a comparatively simplified manner.
These and other objects will become readily apparent as the written disclosure, in its entirety, is studied in connection with the attending drawing.